Plate, Cranioplasty, Preformed, Alterable
Regulation 882.5320
2510(k)s in 12 months (44 all time)
0recalls in 12 months (24 all time)
24recalls that name a 510(k)
Top companies in GWO
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Leibinger GmbH & Co KG | 1 | 19 |
| Stryker | 10 | 0 |
| Osteonic Co., Ltd. | 4 | 0 |
| Biomet Microfixation | 1 | 2 |
| Jeil Medical Corporation | 3 | 0 |
| Osteomed LP | 1 | 2 |
| Synthes | 3 | 0 |
| CraniUS, LLC | 2 | 0 |
| Kelyniam Global, Inc. | 2 | 0 |
| Rion Acoustic Instruments, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2024 | Stryker Leibinger GmbH & Co. KG Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton.
Catalog Number: 56-90614 Open, Classified |
GWO | K182425 |
| Jul 7, 2023 | Osteomed, LLC REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile Open, Classified |
GWO | K111176 |
| Jul 7, 2023 | Osteomed, LLC REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile Open, Classified |
GWO | K111176 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2-
HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium. Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S
The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fi Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S
The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid f Terminated |
GWO | K120352 |
| Aug 6, 2015 | Biomet Microfixation, LLC Thinflap System Case
The cases hold surgical instrumentation in place during handling and storage. Terminated |
GWO | K121624 |
| Aug 6, 2015 | Biomet Microfixation, LLC Neuro Combo Set Case
The cases hold surgical instrumentation in place during handling and storage. Terminated |
GWO | K121624 |
| Apr 24, 2008 | Respironics, Inc. ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
GWO | K922106 |
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